NOTICE OF INTENT TO SOLE SOURCE; FREEZE DRIED PLASMA (W81XWH-20-C-0088 MODIFICATION)

The United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO), intends to execute a modification (W81XWH-20-C-0088) on a sole source basis under the authority of FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements, to Vascular Solutions LLC, 6464 Sycamore Court N, Maple Grove, Minnesota, 55369. This requirement will continue providing necessary equipment, personnel, facilities, and supplies to conduct the objectives in accordance with the contract schedule and proposal titled, - Advanced Development Activities Necessary to Successfully Obtain Commercial Viability of an U.S. Food and Drug Administration (FDA) Licensed Freeze-Dried Plasma (FDP) Product. Vascular Solutions LLC is the only source able to meet the Government requirements. The purpose of this contract is to continue conducting several activities necessary to successfully obtain and sustain commercial viability of an FDA licensed FDP product. This modification will increase the level of effort and extend the contract period of performance end date from 14 September 2023 to 14 September 2024 (12 months). The increase in the level of effort will add additional regulatory, operations, product development, and program management support of and including various manufacturing (stability, PPQ, operational readiness) runs and Biologic License Application (BLA) resubmission. Support also includes activities necessary for manufacturing readiness of product and support for the resubmission of the BLA in the electronic Common Technical Document (eCTD) format that is submitted electronically to the FDA via the FDA's Electronic Submissions Gateway (ESG). Support will also include post-BLA resubmission responses to anticipated FDA inquiries. Vascular Solutions LLC is the regulatory sponsor of the BLA and will manufacture, market, and distribute the FDP product. There are no other FDA approved FDP products available. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. Capability statements are due by 2:00 PM Local Time, June 5, 2023. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov.